Waldemar Link GmbH & Co. KG (Mfg Site): Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

Hazard

Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time

Details from the source

Reason for recall: Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time Distribution: US Nationwide distribution in the state of NH. Quantity: 1 unit Lot/code info: UDI-DI :04026575245253 Lot / Serial Number: C306165

UPC codes

04026575245253

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.